FDA inspection

SUNTECH MEDICAL DEVICES (SHENZHEN) CO., LTD.: FDA inspection ending Jun 12, 2014

FDA inspection 886473 · Voluntary Action Indicated (VAI) · Shenzhen

Key facts

Inspection ID 886473
Firm SUNTECH MEDICAL DEVICES (SHENZHEN) CO., LTD.
FEI number 3006769302
Address Of Building A F 2
City Shenzhen
Country China
Fiscal year 2014
Inspection end date Jun 12, 2014
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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